- Policy
- Govn’t to prepurchase 10 mil of SK Bio’s COVID-19 vaccine
- by Kim, Jung-Ju Dec 24, 2021 05:49am
- The government plans to purchase 10 million courses of domestic COVID-19 vaccine in advance this year. Also, the government will support a total of &8361;545.7 billion on overcoming COVID-19 next year - &8361;321 billion in the development of vaccines and treatments, &8361;119.3 billion in the establishment of research and manufacturin
- Policy
- Domestic approval of EU-approved Novavax is imminent
- by Lee, Tak-Sun Dec 24, 2021 05:48am
- As the European Union (EU) approved the conditional sale of the NovaVax COVID-19 vaccine, attention is being paid to when it will be approved in Korea. As the MFDS is known to be preparing for Novavax's approval for national lot release, analysts say that approval is imminent in Korea. On the 20th, the European Commission (EMA) approved th
- Policy
- The PV guideline amendments may not be applied on Jan. 1st
- by Lee, Hye-Kyung Dec 23, 2021 05:42am
- It is believed that the improvement of the detailed guidelines for the Price-Volume agreement negotiations (PV) prepared by the National Health Insurance Service may not be implemented on January 1st of next year. This is in part due to the authorities’ internal affairs including its reorganization schedules, but also due to the strong op
- Policy
- Kyprolis succeeded in renewing the RSA contract
- by Kim, Jung-Ju Dec 22, 2021 05:56am
- LG Chem's Eutropin Plus 24mg (Human Growth Hormone, Somatropin) and Eutropin Pen are included in the PVA, falling from as little as 1% to as much as 4%. In addition, Amgen Korea's Kyprolis 60mg (Carfilzomib) and Kyprolis 30mg will be adjusted to 4-5% lower prices, respectively, after successfully renewing their RSA contracts. According to
- Policy
- The MFDS approved Spikevax on the 13th
- by Lee, Tak-Sun Dec 22, 2021 05:56am
- The MFDS announced on the 13th that Moderna Korea has decided to allow manufacturing and sales items for Spikevax, which was applied on November 8. Spikevax' is a COVID-19 vaccine produced by Samsung Biologics in Korea with vaccines such as Moderna Spikevax developed in Moderna, USA, which was approved for import on May 21. Samsung Biol
- Policy
- MFDS is speeding up the COVID-19 vaccine screening
- by Lee, Tak-Sun Dec 21, 2021 06:06am
- In 2021, the MFDS focused on speeding up the screening of COVID-19 vaccines aimed at 70% of the nation's vaccinations. As a result, the screening period for COVID-19 vaccines and treatments has been significantly advanced, contributing to the achievement of the goal. Unexpected inspections have begun on manufacturers to cope with illegal ma
- Policy
- What's the HIRA's solution to the drug price?
- by Lee, Hye-Kyung Dec 21, 2021 06:05am
- Measures have been prepared to improve administrative and economic losses caused by drug returns in hospitals, clinics, and pharmacies following the revision of the monthly drug benefit list and upper limit table. The HIRA has decided to provide a revision of the drug benefit list in advance starting this month. Until now, drug price files have
- Policy
- MFDS cancels all Jeil’s hypertension drugs for fabrication
- by Lee, Tak-Sun Dec 21, 2021 06:05am
- The Ministry of Food and Drug Safety issued a disposition revoking the sales licenses of all hypertension drugs manufactured by Jeil Pharmaceutical after the company was found to have submitted fabricated data for approval. A total of 44 items from 15 companies including Jeil Pharmaceutical were issued the disposition. The GMP investigati
- Policy
- Korea tightens social distancing measures again
- by Kim, Jung-Ju Dec 20, 2021 06:11am
- The surge in COVID-19 cases in Korea has led the government to once again tighten the reins on social distancing while focusing on encouraging booster shot vaccinations. Private gatherings will be once again limited to no more than four people in all areas regardless of region, and a ‘vaccine pass’ that differs the level of restrictions
- Policy
- Jeil's JP-1366 has been approved for phase 3 in Korea
- by Lee, Tak-Sun Dec 16, 2021 05:51am
- Jeil's new drug candidate JP-1366 for GERD has been approved for phase 3 clinical trials and is speeding up commercialization. Currently, sales of HK inno.N's P-CAB-based new drug K-Cab are high in Korea. On the 14th, the MFDS approved a phase 3 clinical trial plan for JP-1366 applied by Onconic Theapeutics, a subsidiary of Jeil Pharmaceu
